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Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)

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ClinicalTrials.gov Identifier: NCT01919125
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: IDX719 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of IDX719 in Subjects With Normal and Impaired Hepatic Function
Study Start Date : August 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1: Child-Pugh Class A
Participants with mild hepatic impairment (Child-Pugh Class A score = 5-6) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
Drug: IDX719
IDX719 supplied as 50 mg tablets.
Other Name: Samatasvir

Experimental: Cohort 2: Child-Pugh Class B
Participants with moderate hepatic impairment (Child-Pugh Class B score = 7-9) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
Drug: IDX719
IDX719 supplied as 50 mg tablets.
Other Name: Samatasvir

Experimental: Cohort 3: Child-Pugh Class C
Participants with severe hepatic impairment (Child-Pugh Class C score = 10-15) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
Drug: IDX719
IDX719 supplied as 50 mg tablets.
Other Name: Samatasvir




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Up to 6 days ]
  2. Time to maximum plasma concentration (Tmax) [ Time Frame: Up to 6 days ]
  3. Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last) [ Time Frame: Up to 6 days ]
  4. AUC from time zero to infinity (AUC0-~) [ Time Frame: Up to 6 days ]
  5. AUC from time zero to 24 hours (AUC0-24h) [ Time Frame: Up to 6 days ]
  6. Plasma concentration 24 hours after dosing (C24h) [ Time Frame: Up to 6 days ]
  7. Apparent terminal elimination rate constant [ Time Frame: Up to 6 days ]
  8. Observed terminal half-life (T1/2) [ Time Frame: Up to 6 days ]

Secondary Outcome Measures :
  1. Percentage of participants experiencing serious adverse events (SAEs) [ Time Frame: Up to 6 days ]
  2. Percentage of participants experiencing an adverse event (AE) [ Time Frame: Up to 6 days ]
  3. Percentage of participants experiencing Grade 1-4 laboratory abnormalities [ Time Frame: Up to 6 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Read and sign the written informed consent form (ICF) after the nature of the study has been fully explained.
  • All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug.
  • Male subjects have agreed not to donate sperm from Day -1 through 90 days after the last dose of study drug.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Other clinically significant medical conditions or laboratory abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919125


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01919125    
Other Study ID Numbers: 1894-008
IDX-06A -008
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016
Keywords provided by Merck Sharp & Dohme Corp.:
Chronic hepatitis C
Hepatitis C virus
HCV
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic